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United States · US · US:23155-018_0d5bebf0-11ec-4572-9728-d8721296b1f4

tetracycline hydrochloride

Orange BookUNIISPLATC D06AA04

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
CountryUS (United States)
ATC codeD06AA04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2315501801
    100 CAPSULE in 1 BOTTLE (23155-018-01)

Annotations

UNII (FDA Substance ID)
P6R62377KV
TETRACYCLINE HYDROCHLORIDE
RxCUI 142446
Orange Book
N050278
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "P6R62377KV",
    "rxcui": "142446",
    "inchikey": "XMEVHPAGJVLHIG-FMZCEJRJSA-N",
    "display_name": "TETRACYCLINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "d48071a0-c397-42f8-b8ad-158282e745e3": {
      "match": "brand_token",
      "title": "TETRACYCLINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]",
      "spl_version": "1",
      "published_date": "2026-05-29"
    }
  },
  "productid": "23155-018_0d5bebf0-11ec-4572-9728-d8721296b1f4",
  "productndc": "23155-018",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "050278",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TETRACYCLINE HYDROCHLORIDE",
  "proprietary_name": "tetracycline hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA050278",
  "marketing_category": "NDA",
  "nonproprietary_name": "tetracycline hydrochloride",
  "start_marketing_date": "20240915",
  "active_numerator_strength": "500"
}

Related drugs

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